This trial is active, not recruiting.

Condition asthma
Treatments pictogram-based asthma action plan, aaaai standard of care written action plan
Phase phase 2
Sponsor New York University School of Medicine
Collaborator Feinberg School of Medicine, Northwestern University
Start date July 2011
End date December 2016
Trial size 500 participants
Trial identifier NCT01405625, 09-0358


Asthma has an especially great impact on poor urban children and their families. In addition to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low health literacy. Low health literacy is associated with poorer asthma outcomes. The provision of a written asthma action plan has been shown to help with asthma management and to reduce hospitalizations and ER visits. Poor urban families who may have low literacy may need an alternative asthma action plan to convey the treatment plan.

This pilot study proposes to investigate whether a plain language asthma action plan can improve parent understanding and adherence with medication instructions, compared to standard written materials, among parents of children with asthma. This is an RCT in which parents of children with asthma will be randomized to either receive a pictogram-based low literacy asthma action plan, or a standard action plan (AAAAI), to examine whether those who receive the low literacy plan have improved asthma action plan knowledge when presented with a hypothetical scenario.

A second part of the study is to examine whether providers who are given the pictogram-based low literacy asthma action plan will be more likely to counsel about certain aspects of asthma management (eg. need for daily medications even when sick, spacer use, confusion between everyday and rescue inhaler)compared to providers who receive use a standard action plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a hypothetical patient using the pictogram-based action plan or the standard action plan (AAAAI).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose health services research
(Active Comparator)
Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
aaaai standard of care written action plan
Cartoon/pictogram-based written action plan sheet
pictogram-based asthma action plan
Asthma action plan using plain language, pictograms, and photographs

Primary Outcomes

Asthma Action Plan knowledge (parent)
time frame: 1 day (on same day of enrollment; no outcome assessment after day of enrollment)

Secondary Outcomes

Asthma action plan content (provider)
time frame: same day as presentation of hypothetical counseling scenario

Eligibility Criteria

Male or female participants of any age.

Parent study: Inclusion Criteria: - Primary caregiver / parent / legal guardian of child 2-12 years old - Child with diagnosis of asthma Exclusion Criteria: - Parent not English or Spanish-speaking Provider study: Inclusion Criteria: - Health providers who care for children with asthma

Additional Information

Official title Improving Parent Understanding of Instructions About Asthma Care
Principal investigator Suzy Tomopoulos, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.